Change to the equipment used to extract oils from the fiber bundles.
Device | PRISMAFLEX TPE 2000 WITH PLASMAFILTER PF2000N |
Classification Name | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma |
Generic Name | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma |
Applicant | BAXTER INTERNATIONAL, INC. |
Date Received | 2016-12-02 |
Decision Date | 2016-12-22 |
PMA | P830063 |
Supplement | S009 |
Product Code | MDP |
Advisory Committee | Gastroenterology/Urology |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | BAXTER INTERNATIONAL, INC. 1 Baxter Pkwy. deerfield, IL 60015-4633 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P830063 | | Original Filing |
S024 |
2022-10-18 |
30-day Notice |
S023 |
2022-03-29 |
30-day Notice |
S022 |
2022-03-02 |
30-day Notice |
S021 | | |
S020 |
2021-11-09 |
Real-time Process |
S019 |
2021-05-26 |
30-day Notice |
S018 | | |
S017 |
2020-07-29 |
30-day Notice |
S016 |
2020-03-05 |
Real-time Process |
S015 |
2020-02-24 |
Special (immediate Track) |
S014 |
2019-11-15 |
30-day Notice |
S013 | | |
S012 |
2019-06-27 |
Real-time Process |
S011 | | |
S010 |
2017-10-26 |
30-day Notice |
S009 |
2016-12-02 |
30-day Notice |
S008 |
2015-10-13 |
Special (immediate Track) |
S007 |
2015-05-29 |
30-day Notice |
S006 |
2007-10-09 |
Real-time Process |
S005 |
2006-11-24 |
Normal 180 Day Track |
S004 |
2001-11-13 |
Normal 180 Day Track |
S003 |
2000-10-31 |
Real-time Process |
S002 |
2000-01-18 |
Normal 180 Day Track |
S001 |
1995-07-06 |
Normal 180 Day Track |
NIH GUDID Devices